ANSWERS FDA APPROVES SECOND NICOTINE PATCH FOR OTC MARKETING







T96-53                                       Ivy Fleischer Kupec
August 2, 1996                               (301) 443-3285


FDA APPROVES SECOND NICOTINE PATCH FOR OTC MARKETING

     FDA today approved for over-the-counter marketing NicoDerm
CQ, making it the second nicotine patch smoking cessation aid
available without a prescription for adults.  The following can
be used to answer questions:
     FDA officials approved over-the-counter status for the
NicoDerm patch in 7 mg, 14 mg, and 21 mg strength, as part of a
"step-down" treatment plan.  Available in the United States since
1991 by prescription only, the NicoDerm patch will be sold as an
8-10 week smoking cessation treatment that includes an audiotape,
other user information and a child-resistant disposal tray.
     The NicoDerm patch, when used according to directions,
delivers a continuous, low level of nicotine that helps reduce
nicotine craving and other withdrawal symptoms.  The three doses
allow consumers to gradually reduce the level of nicotine as
treatment progresses.  Heavy smokers (over 10 cigarettes a day)
start with the 21 mg strength NicoDerm patch for the first six
weeks of treatment.  Light smokers (10 cigarettes a day or less)
start at the 14 mg level.  After the initial six weeks, consumers
are advised to lower their dose for an additional two weeks, and 

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            Page 2, T96-53, Second OTC Nicotine Patch Approved
in the case of heavy smokers, they lower their dose a second
time. 
     Many of those who use the NicoDerm patch are able to stop
smoking for at least a few days but may start smoking again. 
Most smokers have to try to quit several times before they
completely stop.  The one-month quit rate among smokers who use
NicoDerm with the accompanying support material is about 19
percent.
     Approximately 35-45 million U.S. adults are addicted to
nicotine.
     Persons with significant heart disease or who take certain
prescription medicines for depression or asthma should consult
their doctors before using the NicoDerm patch.  Some people who
use the NicoDerm patch will experience skin irritation or redness
where the patch is placed on the skin.
     NicoDerm users are directed to stop using NicoDerm if they
experience skin irritation that does not go away or if they
experience irregular heartbeat, palpitations or other symptoms of
nicotine overdose such as nausea, vomiting, dizziness or
weakness.
     SmithKline Beecham Consumer Healthcare of Pittsburgh, Pa.,
markets the NicoDerm patch for ALZA Corporation of Palo Alto,
Calif.
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